(68 days)
Not Found
No
The description focuses on the hardware components and basic control parameters (power, handpiece tip) of a laser system, with no mention of AI or ML capabilities.
Yes
The device is indicated for use in dermatological procedures requiring the coagulation of soft tissue, which is a therapeutic action. Additionally, the description of clinical performance data showing "similar histological effects" implies a therapeutic outcome.
No
Explanation: The device is indicated for use in dermatological procedures requiring the coagulation of soft tissue, which is a treatment function, not a diagnostic one.
No
The device description clearly outlines hardware components such as a console, optical fiber delivery system, footswitch, laser module, and handpiece tips, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in dermatological procedures requiring the coagulation of soft tissue." This describes a therapeutic or surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a laser system that delivers light to tissue. This is consistent with a device used for direct treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue biopsies, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
In vitro diagnostics are tests performed outside of the body on biological samples to diagnose, monitor, or screen for diseases or conditions. The MOSAIC Laser System is a therapeutic device used for treating tissue directly.
N/A
Intended Use / Indications for Use
The MOSAIC Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.
Product codes
GEX
Device Description
The MOSAIC Laser System consists of a self-contained console, an optical fiber delivery system and a footswitch. The MOSAIC produces a beam of coherent infrared (1550 nm) light. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different handpiece tip (5 mm, 6 mm, 8 mm, and 10 mm).
The system console is the heart of the MOSAIC Laser System and contains the optical system (Er-GLASS Fiber Laser Module), Touch LCD, handpiece, system control module with an embedded processor, and power supply module. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the Touch LCD.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data was supplied which showed that the device has similar histological effects as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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pg 1 of 2
510(k) Summary for the Lutronic Corporation MOSAIC Laser System
JUN - 9 2008
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
| | Submitter: | Lutronic Corporation
#403-2,3,4, Ilsan Technotown
1141-1 Baeksok-Dong, Ilsan-Gu
Goyang-Si, Gyeonggi-Do, 410-722
Republic of Korea |
|----|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Maureen O'Connell
O'Connell Regulatory Consultants, Inc.
5 Timber Lane
North Reading, MA 01864
Telephone: 978-207-1245
Fax: 978-824-2541 |
| | Summary Preparation Date: | March 31, 2008 |
| 2. | Names | |
| | Device Name: | MOSAIC Laser System |
| | Classification Name: | Laser Instrument, Surgical, Powered
Product Code: GEX
Panel : General & Plastic Surgery |
3. Predicate Devices
The MOSAIC Laser System is substantially equivalent to a combination of the MOSAIC Laser System (K070392) and the Fraxel II SR Laser System and Accessories (K062303).
4. Device Description
The MOSAIC Laser System consists of a self-contained console, an optical fiber delivery system and a footswitch. The MOSAIC produces a beam of coherent infrared (1550 nm) light. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different handpiece tip (5 mm, 6 mm, 8 mm, and 10 mm).
1
pg 2 of 2
The system console is the heart of the MOSAIC Laser System and contains the optical system (Er-GLASS Fiber Laser Module), Touch LCD, handpiece, system control module with an embedded processor, and power supply module. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the Touch LCD.
5. Indications for Use
The MOSAIC Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.
Performance Data 6.
Performance data was supplied which showed that the device has similar histological effects as the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2008
Lutronic Corporation % O'Connell Regulatory Consultants, Inc. Ms. Maureen O'Connell Regulatory Consultant 5 Timber Lane North Reading, Massachusetts 01864
Re: K080932 Trade/Device Name: MOSAIC Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: May 12, 2008 Received: May 13, 2008
Dear Ms. O'Connell:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Ms. Maureen O'Connell
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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pg \ of 1
| Indications for Use | ||
|---|---|---|
| 510(k) Number (if known): | K080932 | |
Device Name:
Indications for Use:
The MOSAIC Laser System in indicated for dermatological procedures requiring the coagulation of soft tissue.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over The Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Ogden
Page 1 of 1
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K080982